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An Approach to Reduce Uvula Edema After Tonsillectomy

Primary Purpose

Edema

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Edema focused on measuring Dexamethasone, Tonsillectomy, Uvula, Edema, Uvula edema, Post-tonsillectomy

Eligibility Criteria

18 Years - 48 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects with recurrent tonsillitis but no sleep apnea
  • Subjects older than eighteen years old
  • Subjects were planned to have only tonsillectomy procedure

Exclusion Criteria:

  • Subjects who must have additional procedures other than tonsillectomy
  • Subjects younger than eighteen years old
  • Subjects that had intravenous dexamethasone administration perioperatively

Sites / Locations

  • Bezmialem Vakif University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Group 1

Group 2

Arm Description

The patients in Group 1 (n:15) were injected with dexamethasone (1 ml, 8 mg) through the uvula and soft palate tissue directly at three points (three points on the connection of the uvula, and palatum molle) before tonsillectomy .

Group 2 (n:15) patients had tonsillectomy without dexamethasone injection.

Outcomes

Primary Outcome Measures

Efficacy of local dexamethasone administration to reduce uvula edema after tonsillectomy evaluated by using the uvula edema scale
Uvula edema wase evaluated at the postoperative first and fifth days by using the uvula edema scale that the investigators developed.

Secondary Outcome Measures

Full Information

First Posted
March 9, 2017
Last Updated
August 8, 2019
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT03079453
Brief Title
An Approach to Reduce Uvula Edema After Tonsillectomy
Official Title
An Approach to Reduce Uvula Edema After Tonsillectomy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
July 15, 2018 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
April 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A prospective randomized clinical trial that included thirty subjects who underwent tonsillectomy. The patients in Group 1 (n:15) were injected with dexamethasone (1 ml, 8 mg) through the uvula and soft palate tissue directly before tonsillectomy. Group 2 (n:15) patients had tonsillectomy without dexamethasone injection. Patients were examined preoperatively and postoperative on the first and fifth days. In this study investigators tried an approach of dexamethasone application to reduce uvula edema after tonsillectomy.
Detailed Description
Thirty patients between the ages of 18 and 48 years were enrolled in this prospective randomized clinical trial from July 2015 to July 2016. The study was carried out in a tertiary referral center in Istanbul, Turkey. Permission for the study was obtained from Bezmialem Vakif University Clinical Research Ethics Committee, on 03 June 2015, number11/18. The patients in Group 1 (n:15) were injected with dexamethasone (1 ml, 8 mg) through the uvula and soft palate tissue directly at three points (three points on the connection of the uvula, and palatum molle) before tonsillectomy. Group 2 (n:15) patients had tonsillectomy without dexamethasone injection. All patients had the operation under general anesthesia by utilizing the same protocol. Both of the groups were not given iv/im dexamethasone perioperatively. The surgical technique for tonsillectomy was bipolar cautery dissection performed by the same surgeon. The oropharyngeal area was examined and photographed endoscopically preoperatively and postoperative on the first and fifth days. All of the participants were examined with an 8mm diameter 70º endoscope. The photographs of the oropharynx (anterior plicas, tonsils, uvula, posterior oropharynx) were taken by holding the endoscope positioned vertically to the mouth. Blinded observers made examinations of the groups at the postoperative first and fifth days and evaluated the uvula edema by using the uvula edema scale that the investigators developed. The investigators used a scale for grading uvula edema. There is no such scale in the English literature so the investigators developed a scale for grading uvula edema. The investigators grade edema from 1 to 5 as an increase of the edema area. It is called Grade 1 if there was elongation only at the tip of the uvula. If there was edema in the body and base of the uvula, it is called Grade 2. If the uvula edema was spread over a larger area than Grade 2, and if there was involvement in the unilateral plica, it is called Grade 3. If it was spread to both pharyngeal plicas, it is called grade 4. If the uvula edema caused the complete blockage of the posterior pharyngeal tract, it is called Grade 5. The statistical tests were conducted using the Statistical Package for the Social Sciences version 24.0 for Windows (SPSS Inc., Chicago, Illinois, USA). All quantitative variables were estimated using measures of central location (i.e., mean and median) and measures of dispersion (i.e., standard deviation [SD]). Data normality was tested using the Shapiro-Wilk tests of normality. Descriptive statistical analysis were made. Paired t test was used for comparison of intra-group quantitative data. Independent t test was used to compare groups of quantitative data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edema
Keywords
Dexamethasone, Tonsillectomy, Uvula, Edema, Uvula edema, Post-tonsillectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
Thirty patients ages 18 to 48 years who underwent tonsillectomy included in this prospective randomized clinical trial. The patients in Group 1 (n:15) were injected with dexamethasone (1 ml, 8 mg) through the uvula and soft palate tissue directly at three points (three points on the connection of the uvula, and palatum molle) before tonsillectomy. Group 2 (n:15) patients had tonsillectomy without dexamethasone injection.Blinded observers made examinations of the groups postoperative on the first and fifth days and evaluated the uvula edema by using the uvula edema scale that the investigators developed.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
The patients in Group 1 (n:15) were injected with dexamethasone (1 ml, 8 mg) through the uvula and soft palate tissue directly at three points (three points on the connection of the uvula, and palatum molle) before tonsillectomy .
Arm Title
Group 2
Arm Type
No Intervention
Arm Description
Group 2 (n:15) patients had tonsillectomy without dexamethasone injection.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Dexasone
Intervention Description
The patients in Group 1 were injected with dexamethasone (1 ml, 8 mg) through the uvula and soft palate tissue directly before tonsillectomy
Primary Outcome Measure Information:
Title
Efficacy of local dexamethasone administration to reduce uvula edema after tonsillectomy evaluated by using the uvula edema scale
Description
Uvula edema wase evaluated at the postoperative first and fifth days by using the uvula edema scale that the investigators developed.
Time Frame
Postoperative first and fifth days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with recurrent tonsillitis but no sleep apnea Subjects older than eighteen years old Subjects were planned to have only tonsillectomy procedure Exclusion Criteria: Subjects who must have additional procedures other than tonsillectomy Subjects younger than eighteen years old Subjects that had intravenous dexamethasone administration perioperatively
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selahattin Tugrul, Assoc. Prof.
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bezmialem Vakif University
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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An Approach to Reduce Uvula Edema After Tonsillectomy

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